Method, system and equipment for generating submitted data set and file of non-clinical data

Abstract

The invention provides a method, a system and equipment for generating a submitted data set and a file of non-clinical data. The method comprises the following steps: acquiring basic data; the basic data comprises a plurality of non-clinical related data following a preset data standard; utilizing the basic data to formulate basic elements based on an SEND conversion standard; the basic elements comprise non-clinical data; and generating a non-clinical data submission data set and file based on the SEND conversion standard according to the basic elements. Through the method, the problem that an existing algorithm cannot meet the SEND conversion requirement of the non-clinical test data is solved, and the SEND conversion standard-based non-clinical data submission data set and file are automatically generated, so that the non-clinical test development time is shortened, the non-clinical data quality is improved, the non-clinical test cost is reduced, and the success rate of drug research and development is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of non-clinical trials, and particularly to a method and system and device for generating a submission data set and file of non-clinical data. Background Art

[0002] Currently, for non-clinical trials, before all drugs enter human clinical trials, they must provide their safety assessment materials, including: (1) non-clinical animal trial data, which can be extrapolated to the actual effects of this drug; (2) clinical trial data or evidence of the use of the drug in other countries. Non-clinical trials include pharmacological and toxicity tests.

[0003] SEND (Standard for Exchange of Nonclinical Data) is an organization, structure, and format of a standard non-clinical tabular data set for non-clinical research. SEND is an exchange standard, rather than a display format; converting tabular data for display requires the use of software tools to better support viewing and analysis. However, in the prior art, no automated sorting means for non-clinical data submission data sets according to the SEND conversion standard has been proposed, resulting in low efficiency and low accuracy of non-clinical data submission. Summary of the Invention

[0004] Therefore, the present invention provides a method and system and device for generating a submission data set and file of non-clinical data, aiming to solve the technical problems of low efficiency and low accuracy of non-clinical data submission based on the SEND conversion standard in the prior art.

[0005] To achieve the above object, the present invention adopts the following technical solutions:

[0006] According to a first aspect of the present invention, a method for generating a submission data set and file of non-clinical data is provided, and the method includes:

[0007] Obtain basic data; the basic data includes various non-clinical related data that follow a preset data standard;

[0008] Use the basic data to formulate basic elements based on the SEND conversion standard; the basic elements include non-clinical data;

[0009] Generate a non-clinical data submission data set and file based on the SEND conversion standard according to the basic elements.

[0010] Further, the generating a non-clinical data submission data set and file based on the SEND conversion standard according to the basic elements includes:

[0011] Construct a basic element flow chart and a report form based on the basic elements;

[0012] Develop a database specification document based on the basic element flow chart and the report form;

[0013] Construct a database according to the database structure specification document;

[0014] Generate a non-clinical data submission data set and file based on the SEND conversion standard using the database;

[0015] Furthermore, the preset data standard includes at least one of the standards of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the standards of the US Food and Drug Administration (FDA), and the standards of the Center for Drug Evaluation, National Medical Products Administration (NMPA).

[0016] Furthermore, the basic data includes data source data, data set definition metadata, variable-level metadata, value-level metadata, domain model data, and / or calculation algorithm data based on the SEND conversion standard.

[0017] Furthermore, the non-clinical data in the basic elements contains variables and variable labels, and the variable labels are composed of strings.

[0018] Furthermore, before formulating the basic elements according to the basic data, the method further includes:

[0019] Set the project environment, project information, intermediate file storage location, and test data reading period;

[0020] Among them, the project environment and the project information are set according to the non-clinical trial project.

[0021] According to the second aspect of the present invention, the present invention provides a system for generating a non-clinical data submission data set and file, and the system includes: a data acquisition module, a data processing module, and an integration and generation module;

[0022] The data acquisition module is used to obtain basic data; the basic data includes various non-clinical related data that comply with the preset data standard;

[0023] The data processing module is used to process the basic data to generate various intermediate files;

[0024] The integration and generation module is used to integrate the intermediate files to generate a non-clinical data submission data set and file based on the SEND conversion standard.

[0025] Furthermore, the data processing module is further used for:

[0026] Use the basic data to formulate basic elements based on the SEND conversion standard;

[0027] Generate a submission dataset and documents based on the basic elements;

[0028] Construct a basic element flow chart and a report form based on the basic elements;

[0029] Formulate a database description document according to the basic element flow chart and the report form;

[0030] Construct a database according to the database structure description document.

[0031] Furthermore, the system further includes: a data storage module;

[0032] The data storage module is used to store the basic data and / or the intermediate files.

[0033] According to the third aspect of the present invention, the present invention provides a computer device, including a memory, a processor, and a computer program stored on the memory and executable on the processor, wherein the processor, when executing the computer program, implements the method for generating a submission dataset and documents of non-clinical data as described in any one of the first aspects of the present invention.

[0034] The present invention adopts the above technical solutions and at least has the following beneficial effects:

[0035] Through the solution of the present invention, a method, a system, and a device for generating a submission dataset and documents of non-clinical data are provided. By obtaining basic data, the basic data includes various non-clinical related data that conform to a preset data standard; using the basic data, basic elements based on the SEND conversion standard are formulated, and the basic elements include non-clinical data; based on the basic elements, a submission dataset and documents of non-clinical data based on the SEND conversion standard are generated. Thus, the problem that the existing algorithms cannot meet the requirements of SEND conversion of non-clinical trial data is solved, and a submission dataset and documents of non-clinical data based on the SEND conversion standard are automatically generated, thereby shortening the time of non-clinical trial development, improving the quality of non-clinical data, reducing the cost of non-clinical trials, and increasing the success rate of drug research and development.

[0036] It should be understood that the above general description and the following detailed description are only exemplary and explanatory, and cannot limit the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, the following drawings are only some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0038] Figure 1 The flowchart shows the method for generating the submission dataset and documents of non-clinical data provided by an embodiment of the present invention;

[0039] Figure 2 The flowchart shows the method for generating the submission dataset and documents of non-clinical data provided by another embodiment of the present invention;

[0040] Figure 3 The structural diagram shows the system for generating the submission dataset and documents of non-clinical data provided by an embodiment of the present invention;

[0041] Figure 4 The structural diagram shows the system for generating the submission dataset and documents of non-clinical data provided by another embodiment of the present invention;

[0042] Figure 5 The structural diagram shows the physical structure of a computer device provided by an embodiment of the present invention. Detailed implementation manners

[0043] Hereinafter, exemplary embodiments of the present disclosure will be described in more detail with reference to the accompanying drawings. Although the exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments set forth herein. On the contrary, these embodiments are provided so that the present disclosure can be more thoroughly understood and the scope of the present disclosure can be fully conveyed to those skilled in the art.

[0044] It should be noted that, in this document, relational terms such as first and second are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the term "comprising", "including" or any other variation thereof is intended to cover a non-exclusive inclusion, such that a process, method, article or device comprising a series of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article or device. Without further limitation, the elements defined by the statement "comprising..." do not exclude the presence of additional identical elements in the process, method, article or device comprising the elements.

[0045] An embodiment of the present invention provides a method for generating a submission dataset and documents of non-clinical data, as Figure 1 shown, which may at least include the following steps S101 to S104:

[0046] Step S101, obtaining basic data.

[0047] The basic data in the embodiments of the present invention refers to the relevant data for generating non-clinical data submission datasets and documents of the non-clinical data exchange standard. Among them, the non-clinical data exchange standard is abbreviated as SEND.

[0048] In practical applications, the basic data can be collected through a preset electronic data collection system. The electronic data collection system contains a basic element data module for formulating non-clinical data submission datasets and documents based on the SEND conversion standard. The basic element data module is used to collect various non-clinical related data involved in non-clinical data submission datasets and documents based on the SEND conversion standard. These non-clinical related data can be automatically collected through the electronic data collection system or the collection of basic elements can be achieved through the editing and filling by personnel.

[0049] In the embodiments of the present invention, the basic data may include data source data, dataset definition metadata, variable-level metadata, value-level metadata, domain model data, and calculation algorithm data based on the SEND conversion standard, etc. It should be noted that the collection of basic data has strict specification requirements and standardized content, mainly referring to relevant laws and regulations issued by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, the US Food and Drug Administration, and the Center for Drug Evaluation of the National Medical Products Administration as guiding principles and implementation standards. Preferably, the relevant data collected in the embodiments of the present invention for generating non-clinical data submission datasets and documents of the non-clinical data exchange standard mainly comes from the requirements of SEND of the Clinical Data Interchange Standards Consortium (CDISC).

[0050] In the above specific embodiments, the dataset definition metadata includes but is not limited to: demographics, remarks / comments, subject elements, exposure, disposition, body weight, weight gain, clinical observations, cardiovascular, death diagnosis and details, ECG electrocardiogram, food and water consumption, laboratory tests, macroscopic observation results, microscopic observation results, organ measurements, palpable masses, pharmacokinetic concentrations, pharmacokinetic parameters, respiratory test results, subject characteristics, tumor findings, vital signs, trial elements, trial groups, trial sets, etc. Specific examples of the dataset definition metadata collected in the embodiments of the present invention are shown in Table 1 below:

[0051] Table 1 (Examples of Dataset Definition Metadata):

[0052]

[0053]

[0054]

[0055]

[0056] In the above specific embodiments, variable-level metadata refers to that each dataset is described by variable-level metadata definitions, and the variable-level metadata definitions provide information about the variables used in the dataset. Specifically, the following seven different attributes can be used to describe variable-level metadata: variable name (compatible with the SAS v5 transport file format, limited to 8 characters); descriptive variable label, with a maximum of 40 characters, and the label for each variable in the dataset should be unique; data type (e.g., whether the variable value is character or numeric); control term set for the value or variable representation format (control terms, code lists, or formats); source of each variable (e.g., collected or derived); role of the variable, which determines the use of the variable in the dataset. For the SEND domain model, the role is used to represent the category of the variable (e.g., identifier, subject, time; 5 types of qualifiers).

[0057] In the above specific embodiments, value-level metadata refers to, for some variables, the metadata attributes that may require multiple values to describe all the values of the variable. For example, the Organ Measurement (OM) domain may contain subject records related to organ weight and organ ratio. In this case, the origin metadata attribute for some values (collected organ weight) is "COLLECTED"; the origin metadata attribute for some values (derived organ ratio) is "DERIVED". Specific examples of the value-level metadata collected in the embodiments of the present invention are shown in Table 2 below:

[0058] Table 2 (Example of value-level metadata - OM domain [OMTESTCD])

[0059] Source dataset Source variable Value Label Source OM OMTESTCD OW Organ weight COLLECTED OM OMTESTCD OWBW Organ to body weight ratio (or organ - body weight ratio) DERIVED OM OMTESTCD OMBR Organ to brain weight ratio (or organ - brain weight ratio) DERIVED

[0060] In the above specific embodiments, the domain model data may include variables, variable labels, types, controlled terms, code lists or tables, roles, CDISC annotations, and cores. Specific examples of the domain model data collected in the embodiments of the present invention are shown in Table 3 below:

[0061] Table 3 (Domain model data: Demographics - DM example)

[0062]

[0063]

[0064]

[0065] In the above specific embodiments, the calculation algorithm data based on the SEND conversion standard includes: all data calculated using the calculation algorithm based on the SEND conversion standard, where the calculation algorithm based on the SEND conversion standard includes the following steps S1 to S3:

[0066] Step S1: Obtain metadata according to each domain model;

[0067] Taking the variable STUDYID in the domain model DM as an example, obtain the conversion content that conforms to STUDYID from databases or non-clinical trial summary reports from different sources, such as 123-CTOX1. Assign the corresponding variable length according to the actual length of the variable STUDYID, and define the type of the variable STUDYID. For other variables in the demographic data domain model, they are similar to STUDYID. Some variables need to perform numerical calculations, and some variables need to be directly assigned values.

[0068] Step S2: When each variable in each domain model has obtained metadata, unify each variable in this domain model to generate a complete domain model;

[0069] Step S3: Repeat Step S1 and Step S2 until all required domain models are generated.

[0070] It should be noted that all algorithms used in Steps S1 to S3 can be uniformly defined in the algorithm rule center of the electronic data capture system, which is convenient for real-time update according to the SEND conversion standard.

[0071] Step S102: Use the basic data to formulate the basic elements based on the SEND conversion standard;

[0072] It should be noted that after obtaining the basic data, the project environment, project information, intermediate file storage location, and trial data reading period for submitting the data set and generating files of non-clinical data can also be set in the electronic data capture system. Among them, the project environment and project information can be set according to the non-clinical trial project. Furthermore, based on the project environment and project information, the submission data set and file generation for the non-clinical trial project are executed.

[0073] In the embodiment of the present invention, the basic elements at least include non-clinical data. The non-clinical data of the basic elements contains variables and variable labels, and the variable labels are composed of strings. By processing the non-clinical data based on the SEND conversion standard, a high-quality, complete, accurate, and error-free non-clinical data submission data set and file based on the SEND conversion standard can be integrated.

[0074] Step S103: Generate a non-clinical data submission data set and file based on the SEND conversion standard according to the basic elements.

[0075] Specifically, as Figure 2 shown, when the embodiment of the present invention generates a non-clinical data submission data set and file based on the SEND conversion standard according to the basic elements, a variety of relevant intermediate files need to be generated first and integrated, as Figure 2As shown in the figure, it at least includes the following steps S203 to S206:

[0076] Step S201, obtain basic data; (refer to step S101)

[0077] Step S202, utilize the basic data to formulate basic elements based on the SEND conversion standard; (refer to step S102)

[0078] Step S203, construct a basic element flow chart and a report form based on the basic elements;

[0079] Step S204, formulate a database description file according to the basic element flow chart and the report form;

[0080] Step S205, construct a database according to the database structure description file;

[0081] Step S206, utilize the database to generate a non-clinical data submission dataset and files based on the SEND conversion standard.

[0082] It should be noted that in the embodiments of the present invention, for the specific implementation processes of constructing a basic element flow chart and a report form based on the basic elements, formulating a database description file, constructing a database, and finally generating a submission dataset and files, operations can be performed according to the preset template formats for each step respectively. The preset template formats can be set according to actual needs, and the present invention does not make any limitations thereto.

[0083] The embodiments of the present invention provide a method for generating a non-clinical data submission dataset and files. Based on industry experience and domestic and foreign regulations in the industry, by collecting data of non-clinical data submission datasets and files based on the SEND conversion standard, and integrating the data of non-clinical data submission datasets and files based on the SEND conversion standard, high-quality, complete, accurate, and error-free non-clinical data submission datasets and files based on the SEND conversion standard can be obtained, thereby enabling the automatic generation of non-clinical data submission datasets and files based on the SEND conversion standard. Through the present invention, non-clinical data submission datasets and files based on the SEND conversion standard can be automatically generated, thereby shortening the time for non-clinical trial development, improving the quality of non-clinical data, reducing the cost of non-clinical trials, and increasing the success rate of drug research and development.

[0084] Furthermore, as a Figure 1 specific implementation, the embodiments of the present invention provide a system for generating a non-clinical data submission dataset and files. As Figure 3 shown in the figure, the system may include: a data acquisition module 310, a data processing module 320, and an integration and generation module 330.

[0085] The data acquisition module 310 can be used to obtain basic data; the basic data includes various non-clinical related data that comply with preset data standards;

[0086] The data processing module 320 can be used to process the basic data to generate various intermediate files;

[0087] The integration and generation module 330 can be used to integrate the intermediate files to generate a non-clinical data submission data set and files based on the SEND conversion standard.

[0088] Optionally, the data processing module 320 can also be used to utilize the basic data to formulate basic elements based on the SEND conversion standard; construct a basic element flow chart and a report form based on the basic elements; formulate a database description file according to the basic element flow chart and the report form; construct a database according to the database structure description file.

[0089] Optionally, as Figure 4 shown, a system for generating a non-clinical data submission data set and files provided by another embodiment of the present invention further includes: a data storage module 340.

[0090] The data storage module 340 can be used to store the basic data and / or the intermediate files. Among them, the intermediate files include basic elements, a basic element flow chart and a report form, a database description file, and a database.

[0091] Optionally, the preset data standard can include at least one of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use standards, the US Food and Drug Administration standards, and the National Medical Products Administration Center for Drug Evaluation standards.

[0092] Optionally, the basic data can include data source data, data set definition metadata, variable-level metadata, value-level metadata, domain model data, and / or calculation algorithm data based on the SEND conversion standard.

[0093] Optionally, the non-clinical data in the basic elements contains variables and variable labels, and the variable labels are composed of strings.

[0094] Optionally, the data processing module 320 can also be used to set the project environment, project information, intermediate file save location, and test data reading period before processing the basic data; among them, the project environment and project information are set according to non-clinical trial projects.

[0095] It should be noted that for other corresponding descriptions of each functional module involved in the system for generating a non-clinical data submission data set and files provided by the embodiments of the present invention, reference can be made to Figure 1 the corresponding description of the method shown, and details are not described herein again.

[0096] Based on the above method as Figure 1 shown, correspondingly, an embodiment of the present invention further provides a computer-readable storage medium, on which a computer program is stored. When the computer program is executed by a processor, the steps of the method for generating a submission data set and file of non-clinical data described in any of the above embodiments are implemented.

[0097] Based on the above method as Figure 1 shown and the embodiment of the system as Figure 4 shown, an embodiment of the present invention further provides a physical structure diagram of a computer device, as Figure 5 shown. The computer device may include a communication bus, a processor, a memory, and a communication interface, and may further include an input / output interface and a display device. Among them, each functional unit can complete mutual communication through the bus. The memory stores a computer program, and the processor is used to execute the program stored on the memory to implement the steps of the method for generating a submission data set and file of non-clinical data described in the above embodiments.

[0098] Those skilled in the art can clearly understand that the specific working processes of the above-described systems, devices, modules, and units can refer to the corresponding processes in the foregoing method embodiments. For the sake of brevity, they are not described herein again.

[0099] In addition, in each embodiment of the present invention, the functional units may be physically independent of each other, or two or more functional units may be integrated together, or all functional units may be integrated in a processing unit. The above integrated functional units can be implemented in the form of hardware, or in the form of software or firmware.

[0100] Those of ordinary skill in the art can understand that if the above integrated functional units are implemented in the form of software and sold or used as an independent product, they can be stored in a computer-readable storage medium. Based on this understanding, the technical solution of the present invention, in essence, or all or part of the technical solution, can be embodied in the form of a software product. The computer software product is stored in a storage medium, which includes several instructions for causing a computing device (such as a personal computer, a server, or a network device, etc.) to execute all or part of the steps of the method described in each embodiment of the present invention when running the instructions. The foregoing storage medium includes: various media such as a USB flash drive, a mobile hard disk, a read-only memory (ROM), a random access memory (RAM), a magnetic disk, or an optical disc that can store program codes.

[0101] Alternatively, all or part of the steps of implementing the foregoing method embodiments may be accomplished by hardware associated with program instructions (such as a computing device such as a personal computer, a server, or a network device), and the program instructions may be stored in a computer-readable storage medium. When the program instructions are executed by a processor of the computing device, the computing device performs all or part of the steps of the methods described in the embodiments of the present invention.

[0102] Finally, it should be noted that: the above embodiments are only used to illustrate the technical solutions of the present invention, rather than limiting them; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that within the spirit and principle of the present invention, it is still possible to modify the technical solutions described in the foregoing embodiments, or perform equivalent replacements on some or all of the technical features; and these modifications or replacements do not cause the corresponding technical solutions to deviate from the protection scope of the present invention.

Claims

1. A method for generating a submission data set and file of non-clinical data, characterized in that: The method comprises: Acquiring basic data; the basic data includes a variety of non-clinical related data that comply with preset data standards; Using the basic data, developing basic elements based on the SEND conversion standard; the basic elements include non-clinical data; Generate non-clinical data submission data sets and files based on the SEND conversion standard according to the basic elements.

2. The method according to claim 1, characterized in that The generating of non-clinical data submission data sets and files based on the SEND conversion standard according to the basic elements includes: Constructing a basic element flow chart and a report table based on the basic elements; Develop a database description document based on the basic element flow chart and report form; Constructing a database according to the database structure description file; The database is used to generate non-clinical data submission datasets and files based on the SEND conversion standards.

3. The method according to claim 1, characterized in that: The preset data standards include at least one of the standards of the International Council for Harmonization of Technical Registration for Pharmaceuticals for Human Use, the standards of the U.S. Food and Drug Administration, and the standards of the Drug Review Center of the National Drug Administration.

4. The method according to claim 1, characterized in that The basic data includes data source data, data set definition metadata, variable-level metadata, value-level metadata, domain model data and / or calculation algorithm data based on the SEND conversion standard.

5. The method according to claim 1, characterized in that The non-clinical data in the basic elements include variables and variable labels, and the variable labels consist of character strings.

6. The method according to any one of claims 1 to 5, characterized in that: Before formulating the basic elements according to the basic data, the method further includes: Set up the project environment, project information, intermediate file storage location, and test data reading cycle; Among them, the project environment and the project information are set according to non-clinical trial projects.

7. A system for generating a submission data set and a file for non-clinical data, characterized in that: The system includes: a data acquisition module, a data processing module, and an integration generation module; The data acquisition module is used to obtain basic data; the basic data includes a variety of non-clinical related data that follow preset data standards; The data processing module is used to process the basic data and generate a variety of intermediate files; The integration generation module is used to integrate the intermediate files to generate non-clinical data submission data sets and files based on the SEND conversion standard.

8. The system according to claim 1, characterized in that The data processing module is also used for: Using the basic data, develop basic elements based on the SEND conversion standard; Constructing a basic element flow chart and a report table based on the basic elements; Develop a database description document based on the basic element flow chart and report form; Construct a database according to the database structure description file.

9. The system according to any one of claims 7 to 8, characterized in that: The system further comprises: a data storage module; The data storage module is used to store the basic data and / or the intermediate file.

10. A computer device comprising a memory, a processor, and a computer program stored in the memory and executable on the processor, wherein: When the processor executes the computer program, the method for generating a submission data set and file of non-clinical data according to any one of claims 1 to 6 is implemented.

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